Clinical Assessment - HominisTM Surgical System

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04109989

Enrollment

Registered

2019-10-01

Start date

2018-11-08

Completion date

2021-12-30

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Brief summary

A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.

Interventions

DEVICEHominisTM Surgical System

Trans-vaginal gynecological procedures

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Female above 18 years of age inclusive. 2. Able to provide written informed consent. 3. Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery. 4. Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System. 5. Fit for robotic-assisted transvaginal surgery based on surgeon discretion. 6. Can undergo general anesthesia per anesthesiologist assessment.

Exclusion criteria

1. Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliterated vagina or sever recto-vaginal endometriosis). 2. Women after pelvic radiation. 3. Women diagnosed with active intra-abdominal malignancy. 4. Women with general condition or illness incompatible for surgery. 5. Women who are pregnant. 6. Unwillingness or inability to follow the procedures outlined in the protocol.

Design outcomes

Primary

Measure	Time frame	Description
Rate of conversion	Intra Operative	Rate of conversion to open or laparoscopic approach

Secondary

Measure	Time frame	Description
Intra-operative & post-operative procedural outcomes	Intra-operative and six weeks post procedure	Intra-operative & post-operative complications
Intra-operative procedural outcomes	Intra-operative	Operative time
Post-operative procedural outcomes	Six weeks post procedure	Length of hospital stay
Vaginal tissue healing	Six weeks post procedure	Vaginal tissue healing will be assessed

Countries

Belgium, Israel

Contacts

Primary ContactLimor Kuznits, B.Sc

Limor@memicmed.com+972-54-630-20-12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026